Description

Trenbolone Acetate Usp Impuritya CAS NO 53303-85-8 is a high-purity chemical reference standard, specifically identified as a key impurity in the analysis of Trenbolone Acetate. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products and active pharmaceutical ingredients (APIs). It is primarily required by analytical laboratories, quality control departments, and research institutions within the pharmaceutical and biotechnology sectors for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Trenbolone Acetate bulk drug and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to meet ICH Q3A(R2) and Q3B(R2) guidelines for impurity control.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure the accuracy and precision of impurity assays.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Stability Studies: Employed to monitor the formation of this specific degradant in stability testing of Trenbolone Acetate under various ICH-prescribed conditions.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and chemical behavior of Trenbolone Acetate.

Basic Information

Product Name	Trenbolone Acetate Usp Impuritya
CAS No.	53303-85-8
Molecular Formula	C20H24O3
Molecular Weight	312.41 g/mol
Synonyms	17β-Hydroxyestra-4,9,11-trien-3-one 17-acetate Impurity A; δ9,11-Trenbolone Acetate; Estra-4,9,11-trien-17β-ol-3-one acetate; Trenbolone Acetate Related Compound A; 19-Norandrosta-4,9,11-trien-17β-ol-3-one 17-acetate; Finaplix Impurity A; Parabolan Impurity
EINECS	Contact for details

Quality Control

This high-grade impurity standard is manufactured and controlled under a strict quality management system. Each batch is characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC, to confirm identity and purity. Certificates of Analysis (COA) are provided, detailing batch-specific results for assay, related substances, and residual solvents, ensuring traceability and compliance with USP and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.